[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS AND SECURITY

Ju1y 27, 2005

Hubert H. Humphrey Building
200 Independence Avenue, SW
Room 800
Washington, D.C. 20201

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 180
Fairfax, Virginia 22030
(703) 352-0091

TABLE OF CONTENTS

Subcommittee Planning for Future Meetings


P R O C E E D I N G S (8:40 a.m.)

DR. REYNOLDS: Good morning. My name is Harry Reynolds, and I am co-chair along with Jeff Blair of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. NCVHS is a federal advisory committee consisting of private citizens, and makes recommendations to the Secretary of HHS on health and information policy.

On behalf of the subcommittee and staff, I want to welcome you to today’s hearing, where we will discuss some of our future plans. We are being broadcast live over the Internet, and I want to welcome our Internet listeners as well.

I would request that everyone turn off their cell phones, and also during the hearing if we all speak clearly into our microphones, those on the Internet will be appreciative.

As is our custom, we will begin with introductions of the subcommittee staff and guests. I would invite subcommittee members to disclose any conflicts of interest. Staff and guests need not note any conflicts. I will begin by noting that I have no conflicts of interest.

MR. BLAIR: Jeff Blair, Vice President of the Medical Records Institute, co-chair of the Subcommittee on Standards and Security. I don’t have any conflicts of interest regarding these topics that I am aware of.

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the subcommittee and liaison to the full committee.

DR. HUFF: Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City. I don’t know of any conflicts for the subjects that we are discussing today.

DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of the subcommittee. I’m not aware of any conflicts that I have with today’s agenda.

MS. GOVAN-JENKINS: Wanda Govan Jenkins, NCHS, CDC, Health Informatics Specialist, and I am staff to the Standards and Security group.

MS. BEEBE: Susan Beebe, ASPE, staff to the subcommittee.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and Quality, liaison to the full committee and staff to the subcommittee.

DR. COHN: I am Simon Cohn, Chair of the committee and a member of the subcommittee. I am Associate Executive Director for Health Information Policy for Kaiser Permanente. I have no conflicts of interest.

I do want to take a moment and recognize and welcome a new staff member, which we didn’t acknowledge yesterday, Wanda Govan Jenkins. She is a new employee of NCHS, and we are happy to have her joining us. Thank you.

DR. FRIEDMAN: Maria Friedman, CMS, lead staff to the subcommittee.

MS. SQUIRE: Marietta Squire, CDC, NCHS and staff to the subcommittee.

DR. GILBERTSON: Lynn Gilbertson, National Council of Prescription Drug Programs.

MS. WILLIAMSON: Michele Williamson, National Center for Health Statistics, CDC and staff to the NHII work group.

MS. SIGMANUKE: Marilyn Sigmanuke, America’s Health Insurance Plans.

MS. BICKFORD: Carol Bickford, American Nurses Association.

DR. REYNOLDS: Our goal today is to — actually, I have a little bit of time to discuss — if anybody wants to discuss further anything that went on yesterday, and then do a little planning for our future meetings, make sure that we have ourselves set accordingly. So if anybody has anything to reiterate on yesterday or thoughts that came up, and then we will move into that. I will make one quick comment and then turn it over to Michael.

Stan, great job. Last night was a chance to step back from everything we heard yesterday. I thought that was a great opening salvo into that subject. Thank you for the effort and to the people that did it.

DR. HUFF: You’re welcome.

DR. REYNOLDS: It took us into a new world that some of us were uncharted in.

DR. FITZMAURICE: I also want to say how much I appreciate what Stan did and Maria did in pulling together those speakers. It was better than your typical graduate seminar that I get when I come to NCVHS meetings. It is exciting, because it continues to open up a pathway that started with the report for patient medical record information. I guess Congress knew what they were doing when they gave the charge to NCVHS.

I think the interesting part in the future will be to work with the private sector to define what are the most important use cases, that is, where can we find value in working to improve vocabulary, a common medical terminology, coding systems, and then secondly, how can we support the private sector in having places where they can get things.

We heard yesterday that, if there were places I could go to look for code sets, to see if somebody else has done it before I invent one, or if we have three of them and we have to choose, if there were criteria for making the choice easier, it wouldn’t be, I am the biggest company, I am going to be around, and so you use my code set. There are a lot of questions that it is going to be a pleasure to tackle. I think we have a good group with which to tackle them.

Thank you, Harry.

Agenda Item: Subcommittee Planning for Future Meetings

DR. REYNOLDS: Any other comments? Let’s move into looking forward at some of our future meetings. Jeff and I spent a little time this morning, and Judy joined us, and I just spoke briefly with Simon. As we try to set up our ongoing hearings, we tried to put a little framework around some things we could think about and maybe three distinct areas of things we do. One is future areas of interest, and I think Stan’s session yesterday was a perfect example of that.

As we have mentioned in other meetings, we have asked Judy to take a lead on a category we are going to call matching records to patients, which is another future view. One of the goals of NCVHS has always been to be a little bit ahead at times, so we need to make sure that we clearly mark some of our time and some of our hearings to make sure that we continually remind ourselves to stay ahead on some subjects. So that would be one category.

A second category would be new regs or subjects. So for example, we have a number of new regs, once the claims attachment becomes a reg, once any of the other things that come out that are going to be new, those would fall into that category. A good example is, even though it is an old subject, things like Jello yesterday and some of the other things that came out that were part of discussions that were maybe new ways of looking at decision support or other things g could fall into that category.

Then a third that also continues to be an important part of what we do, and we haven’t all agreed on whether these words are right or not, but Simon gave an oversight of current initiatives. I think yesterday morning was a good oversight of current initiatives, and what Lynn Gilbertson and the others did as far as what was going on with NCPDP and others.

So if we take those as a framework and make sure that we continually set up our agendas so that we don’t get really focused just on one type of thing, we are playing in all of the arenas that we are supposed to be in, and doing that in a way that allows us to be of value in each of those categories, and that may be a way to structure it.

So as we think of moving forward, trying to keep that in mind, I want to have some open discussion on these ideas we just worked on a little bit ago.

DR. FITZMAURICE: Could you go back to the one, two, three again?

DR. REYNOLDS: The first is future areas of interest. For example, secondary use of information was one that could fall in that category. Then we have the idea of new regs or subjects, new regulations or subjects. That is the second one, because there are new regulations coming off, but there are also new subjects that we may want to look at, not necessarily futuristic, but it may be a subject that comes up based on what we have been doing that already plays with something. Then — and again, this last one we have to vet — oversight of current initiatives. We still have a lot left in HIPAA that we wanted to take a look at. As it continues to go, we haven’t finished the ROI there. We still are going to keep a close eye, especially with the dates we got yesterday on e-prescribing and other things. So that would be that category. So as we set up these hearings, that would be the structure.

Then if we keep in mind maybe three key premises for us, are we trying to lead, evaluate or recommend, is also another way to overlay on those for what we want to have come out of it.

So that is just the discussion that we had earlier, and I wanted to put the framework out there, as we set these next couple of hearings up.

Obviously, there is no question, part of what Simon has been working on with the Secretary and so on, we could get requests to help, and those requests could fall into any of these categories, based on what is going on and as fast as everything is moving right now. But again, it gives us a sense that we don’t get stuck in one particular area.

I think Simon made a good point at dinner last night; NCVHS tries at times also to be ahead in its thinking on some things, and we don’t want to lose sight of that with so much going on right now, that could keep you in the current. There are plenty of things going on right now that could keep us in the current forever without stepping forward.

DR. FITZMAURICE: I would like to urge us to continue the updating parts of our meetings and our agenda, not only Department updates, but — and this may come under future areas of interest or new areas — look around to see what is coming down the road. Often the Department is the leader in this, but many times the private sectors say, we have a need. So just recognizing the need can be an area of interest, even if we don’t have a solution at the time. We might recommend to the Secretary that the Secretary take a look at something or try to resolve a problem.

For me yesterday, Jello was kind of a new thing, and nobody was sure if it was going to work or not, but it does seem to be worth a second glance. I’m sure there are other things out there.

So I like the updating that we do. It keeps us current on what is going on, and for that we rely upon the private sector as well as the Departmental people to keep us abreast.

DR. REYNOLDS: And I would consider those in new regs or subjects, those continuous updates. We don’t oversee those areas, but they could fit in there.

MR. BLAIR: Just to add a little bit more flesh to these bones — by the way, Harry from what I could tell really took the lead in trying to pull together this framework. I think that it is just excellent to help us begin to think about how we think about our new activities, as well as how we represent ourselves to the Secretary.

On the first topic which is futures, could we maybe have — I would like to suggest a sub-item under futures, which I would call defining future standards directions. The reason that I am suggesting that, defining future standards directions, is that in the PMRI report of 2002 we did that. I think that the work that Stan is doing right now is going to be defining future standards directions. I think that that may help somebody like the Secretary understand what we mean when we are saying futures.

Another item under futures I think is identifying requirements for standards interoperability. That is another sub-item under futures that I think we should make sure the Secretary understands is an area where we could contribute.

So those are just some thoughts.

DR. REYNOLDS: Other comments? If you wouldn’t mind, I’d like to hear from each of the committee members, if you like the idea, if you think it is a structure that we could at least play with, or do you just want to continue working as we are, with things out there that we want to do. Again, I don’t care which way it goes. I just want to make sure that we do move forward in a direction.

DR. WARREN: This morning I asked to meet with Jeff and Harry in order to help give me direction of pulling together a panel on looking at matching records to patients, so that we could get the right data to the right caregiver or person responsible for that care at a point in time, or it could be getting that data to a bio surveillance project, or getting the data to a Public Health Service initiative.

When we started talking about this, that was when Harry started sharing this framework. It occurred to me at that point that it might be helpful for us, whenever we are doing an annual report or making a report back to the full committee, to frame the work that we do here within that.

I also like the idea of almost putting this together in a matrix, where you have as your columns the future areas of interest, the new regulations or subjects, and the oversight of current initiatives, and the rows would be this lead, evaluate and recommend. I think that we fill in those cells a little bit differently. You can also show actual movement of where the committee is as we start moving our activities from one cell to another through this.

It also provides me with a better guidance of how to pull testimony together for the subject that I am putting together, and looking at what is happening in the future, are there any previous projects that have been evaluated, has there been any work that has been done by, as Mike said, different departments within HHS attacking the same issue.

So I guess I am in full support but then, I just spent the last 45 minutes talking with Jeff and Harry, so I have bought into the whole conceptualization of this. Does that help, Harry?

DR. REYNOLDS: Yes, very much.

DR. HUFF: I think it is a good framework for thinking about our work. I think it would be great if we received some new assignments, specifically things that the Secretary thinks we can help with. I think that would be great. But I think all we can do is encourage or let them know that we are available for that.

I think it is in fact a very good subject for us to pursue the matching patients to data. I think there are issues there that haven’t been resolved, and I noted that Clem noted yesterday that in order to advance the idea of this secondary use of data, that that is one of the things that we have to do, is match patients; is it matches over time, and to understand the outcomes, you have to understand that it is the same patient now as it was back a year ago or two years ago or whatever.

So I like the framework. I like that particular work item. I think there is a lot to be explored there. Maybe a lot of it is just — I think some other people have been exploring and making some suggestions about that.

Of course, I think we are just starting to investigate the subject of secondary data use, and haven’t had a chance to formulate at all. But even with the testimony we heard yesterday, it is maybe time to start making a list of things that people said would help make that more efficient.

I think that is probably all I have thought about so far.

DR. COHN: I think the framework is very attractive. I think certainly the buckets of current initiatives and then the two buckets of new regs and subjects are very appropriate. I might quibble a little bit with how you identified the issue of what is in current initiatives, because yesterday morning I’m not sure I was hearing a lot about current initiatives. I was hearing a lot more about things that were a quarter step ahead. I didn’t hear anything that was how NCPP is doing with the current things that are out there. I heard about all the new stuff. But that is a quibble, what goes into what box.

The lead, evaluate and recommend, as much as I understand it, and I guess I would have to think about it, is probably not a bad way to frame this, though I do tend to think in my own mind that at the end of the day, what we wind up is a — what we need is a balanced portfolio. There are things that — back when I was Chair, I used to keep a list of activities as well as times they needed to come up, which was much more informal. I like this much better.

For each topic, my view is that you move from — you end up with a project plan for any item that you tried to get into, which I know is where Jeff has been, and I think we have seen with other projects which we evaluate and recommend. I would hate to see us do too many things where we stayed up at such a high level that we don’t wind up at some point with a recommendation.

So I think the balanced portfolio is a good one, as long as we don’t suddenly start deciding that all we have to do is lead or evaluate. That is not where our value is. I think we need to move to recommendations.

I guess what you are hearing is support on it. I think we just have to figure out where the sweet spots in all of this are in terms of the actual items.

DR. REYNOLDS: I like your idea of a balanced portfolio. That is a very succinct way of saying just what we put together. Any staff?

DR. FRIEDMAN: I like the framework. There is so much good stuff going on out there. What Simon said about finding the sweet spots and balancing the portfolio is appropriate. I think it is going to be a challenge for all of us, given all the myriad of activities to choose from, what we are going to choose and how we are going to —

DR. REYNOLDS: We didn’t say the list was short or was going to be easy to put in here. We are just trying to come up with some way to think about it, so that we make sure also that we don’t get stuck in any one half.

DR. WARREN: Just a comment back to Maria. One of the things that we talked about this morning was trying to come up with a fairly concise way that we could tell other people what we were about, instead of giving them a landry list of projects that we were on. One of the dangers of a long list of projects is, someone can look at that and say, this is not important for you to engage in, and you don’t need to spend time there, without fully understanding what may come out of that project. I think we have had a lot of interesting wins come out of what we have done in e-prescribing that we did not intend or even think would happen when we went into it, such as the collaboration between HL-7 or NCPDP. Yet, that clearly shows how we provided some leadership to come back and then we continue to evaluate what is happening with that, and then at some point we are going to be making recommendations to take these harmonized standards forward.

So it is from that kind of perspective, of putting a framework around to explain what we do. I think the difficulty is, sometimes we do tend to think in laundry lists because it is easier for us to do. When you try to put context and meaning around it so that you can explain it in a succinct way to others what you are about that we run into these problems.

DR. FRIEDMAN: I don’t disagree with that, Judy. I think it is very important to do that. I also think it would be very helpful for those of us who write the reports and try to get our arms around what we have done, at some point in time for whatever purpose. I think having a framework is good. It goes down to selection, because there is just so much good stuff out there.

DR. WARREN: I think that is the biggest challenge.

DR. REYNOLDS: It doesn’t change that challenge. Any other comments before we start actually deciding what we want to do?

MS. BURKE-BEBEE: I like the framework as well. The third one where it refers to oversight, I am wondering if that is inclusive of coordinate, because there are a lot of other initiatives that are going on that we all need to coordinate, which extends what Judy said to the more definitive of what we are doing, so that it is clear and not duplicate other efforts, but also coordinate what we are doing with the other efforts out there.

DR. WARREN: When you talk about coordinate, Susie, do you see that as being subsumed under what we are talking about? We are still not sure of the words on here, so the words are still open for selection. But you are concerned about coordination, and Mike brought up some of the coordination issues too between the different agencies.

MS. BURKE-BEBEE: I am even thinking of the new commission, AHEC, and how we would coordinate with those efforts. That certainly isn’t an oversight role, but it is a coordination role. So I wasn’t sure where it fell within these three.

DR. WARREN: Would you see that it would be part of new regulations and subjects? This would be a new activity coordinating with AHEC?

MS. BURKE-BEBEE: It could be, but it definitely needs to be somewhere.

MR. BLAIR: One of the thoughts that I had was that I have seen how the subcommittee has evolved over the last eight years. It seemed as if we had a very clear mandate eight years ago that our recommendations went to the Secretary, and that was our focus.

As time went on, while that was still our primary focus of our recommendations; the letters were written to the Secretary. This last year, when we were doing the e-prescribing recommendations, for example, it became clear that some of our recommendations wound up going to the industry or to agencies, and indirectly to Congress. So it seems as if more and more, we have three audiences, which is the Secretary, Congress and the industry. I don’t know how that should be reflected. Judy had suggested a matrix, so maybe that is going to be part of the matrix, is the audience that we serve.

So that was just a thought that you might want to fold in somehow.

DR. FRIEDMAN: I’ll respond to Susie’s comment about coordination, because coordination has also been a role of NCVHS, not so much in this subcommittee but in others. I am thinking about Populations in particular.

There are new coordination activities such as with AHEC, and then there is the other stuff we have been typically coordinating all along. I don’t know what bucket you want to put those in.

MR. BLAIR: Well, coordination relates to them all, so I almost feel like it is a different dimension rather than one of the three. I think it is important. We definitely are going to coordinate with AHEC. We do coordination with a number of different entities.

I don’t know if I would set up a fourth category, because I think coordination applies to all three.

DR. COHN: Let me chime in also. I don’t think coordination is a separate action. That is something you do when you are setting up priorities. That is something you do as you do a project or whatever, but it doesn’t feel like a separate thing here. Jeff, I’m just supporting your comment.

DR. WARREN: In looking at this, we talked about the threads that we have are this lead, evaluate, recommend. Maybe another thread should be coordinate, and have that apply to everything, so that we don’t drop the notion.

DR. FITZMAURICE: I’m not sure that we coordinate. We have the luxury of being a learned body who can apply the best minds of the country to some of the problems. We can point out areas that need coordinating. We can show what the gains can be. We certainly coordinate our own agenda, but beyond that, I think it is applying our minds to prod other people to coordinate, to take an overview and to say, look at the gains. If you talk to this person or if you two got together and made it one standard.

By golly, people listen to what the NCVHS says. I think of coordination as being more directive, or you should do this and you should do that, whereas we say, look at the gains that would come if you do that. So I think coordination is something that we do for ourselves, and we urge other people to coordinate among themselves.

DR. STEINDEL: I have two comments. One is basically the same comment as Mike just made, on the observations about coordination. I don’t view it as a separate activity, I view it as something that is inherent in what we do and what we recommend being done, but the NCVHS itself can’t really do coordination, except in a very limited sphere.

But the other comment I would like to make is concerning the three bins that Judy laid out at the top, lead, evaluate and recommend. I have been pondering on that. I don’t have a problem with the three topics. I have a problem with the order of the topics.

I think what we should be doing, I look at it as more lead/evaluate, and the next topic is recommend — or excuse me, lead/recommend, and then the other topic, evaluate, because that is what we primarily do. We establish a leadership position in some areas and make far-reaching statements. Usually with respect to those far-reaching statements, we tend to start making more and more specific recommendations as we study that issue over time.

I think the NHII report is a very good example of that. In some areas we had very specific recommendations, including the development of the office of the national coordinator, and in some areas we had very vague recommendations, which we are now starting to solidify. One of them is secondary uses of data that Stan did a wonderful job of kicking off yesterday. But those two come together as one area, and then evaluation is what we do as we look at these things over time. We asked people, where is the NHII report sitting today? Where should we be moving forward from it?

So I really looked at it as two columns, and one part of the column, I looked as somewhat a continuum.

MS. GOVAN-JENKINS: Just to piggyback off what Jeff was saying about interoperability. The EHR group is currently defining what interoperability is. I just wanted to suggest as Jeff did, maybe we can look into this further to better understand what interoperability is as a route, and what the standards are.

DR. REYNOLDS: Okay, are we ready to start deciding on the next few hearings?

DR. STEINDEL: If we are going to start deciding the next few hearings, I would like a recommendation that we stay off of EHR interoperability. Sorry.

There are two main reasons I say that right now. That is, number one, there are two major groups that will be looking into the issue in the very near future. One Office of the Secretary is the HL-7 EHR work group, which has extensive work going on in the whole question of interoperability of EHRs. The second is what is going to be kicking off from the RFP process.

I think the time for us to start looking at EHR interoperability is approximately maybe a year from now, when those efforts start crystallizing and can start reporting. But for us to look de novo at EHR interoperability, we are just going over areas that other people are doing right now.

MR. BLAIR: Can I just do a little refining on that, if I may? I think your observations are absolutely correct.

My thought is — and see if you think that this is on target — that when we do begin to focus, the added value we could offer is the requirements of interoperability among standards among terminologies as opposed to the subject of interoperability per se. Do you think that is proper?

DR. STEINDEL: Yes, I think that is very proper. We are going to be looking at evolving from the RFP process, if it develops legs, is the standards harmonization group that will be starting to enunciate what is involved with the standards for EHR interoperability. But I don’t think that is going to prove to be a definitive answer for everything. I think those edge issues, which is what I think you are talking about, is where we are going to have to start looking.

DR. COHN: Without getting to the substance of what Steve was talking about in terms of timing, I do want to observe that in all of this, timing is critical. Somehow in our framework we haven’t described that.

The way I handled it in my Microsoft Word list was noting that things were important issues, but needed to be checked at X time. So the fact that it may not be ready for the next three to six months doesn’t mean that it shouldn’t be on our list. It should have that we should be looking at it around X. So I just wanted to be sure that given that it may not be part of our next three hearings doesn’t take it off the table.

DR. REYNOLDS: Again, we are only putting this out so that we can all think of some kind of structure, is to go ahead and take our subjects we already know are on the calendar, some of them that are continuously involved, map them to this, and then everybody have the same framework and we can make sure we are double checking against everything that needs to go on.

Obviously as we know, we could end up getting an assignment from them or others that would supersede whatever we planned for our next. We know that this hearing was going to be with the DEA, so we changed that and we have to adjust accordingly. But it at least gives us a framework to think about it and make sure that we are adding and subtracting the thing in order.

Our next hearing is September 21 and 22.

DR. COHN: This has to do with our discussions yesterday. I thought they were fascinating. I apologize, I was not in for them all, but I think we all observed that not only was it important for this subcommittee, but for others.

Indeed, one of the conversations we ought to have is whether or not we need to somehow at a full committee meeting a la November or something like that bring everybody up to speed. It isn’t very useful to tell them about all the wonderful things we heard and then have them go off and have the same presenters come to the Quality work group, come to the Populations subcommittee, NHII, on and on and on.

So I just want to open up that additional dimension here, that not everything that we talk about that is important has to be just at the subcommittee level. There may be things that we want to elevate to the full committee saying, yes, we looked at this one, we want everybody to hear more about it, we want to spend a half day at a full committee meeting, because this is one of the foundational things that is of general importance that you all need to be thinking about how it impacts your work plan. That is called the committee working together.

So I just want to make sure that we aren’t just — if the only thing we did yesterday is figuring out more subcommittee actions, I think we might be missing an opportunity there.

DR. REYNOLDS: I think another dimension we can consider is, is what we are working on something reasonable for the full committee or is it something we have to keep an eye on.

For September, I’ve got a list of a number of things. I just tried to go through and list them by category, and an awful lot of them fall in one and two. I’ll just read you a list of things.

The e-prescribing final rule, Stark and Safe Harbor, NPRMs, the e-prescribing pilot.

MR. BLAIR: When you say NPRMs, NPRMs related to what topic?

DR. REYNOLDS: E-prescribing.

MR. BLAIR: So it would be NPRMs for the pilot test?

DR. REYNOLDS: That is the next one.

DR. FRIEDMAN: No, these are NPRMs for e-prescribing.

MR. BLAIR: Then it is the final rule?

DR. FRIEDMAN: No, these are —

MR. BLAIR: Then I am confused.

DR. FRIEDMAN: Let me back up. We have a final rule coming out on the foundation standards. Then because there are requirements in the Medicare program for accepting things like hardware and software and training, people needed guidance under anti-kickback and Stark exceptions, as to what would be permissible for e-prescribing purposes. So we are coming out with some guidance on that pretty soon. That is separate.

You can think of these as a suite of regs related to e-prescribing.

DR. REYNOLDS: We also have the claims attachment rule, and then we have got the NPI HIPAA mods regulation, and we have got ONCHIT RFPs, OESS RFI on personal health record, the next round of CHI, Departmental updates, something on the 500-day plan, continued updates on e-prescription like yesterday, whether or not we want another review on the continued progress of the sig and the HL-7 NCPDP harmonization, we’ve got HIPAA ROI. I forget whether or not we want to do anything further with secondary use, if we want to go ahead and kick off our discussions on matching records, patients, and if Simon gets us any other assignments prior to September.

MR. BLAIR: I am a little reluctant for us, unless the Secretary asks us, to make comments or judgments on the RFPs. I think that could be — I’m not sure that that would be viewed as constructive or helpful, unless we are asked to do it. So that is one.

There are three things which I personally would love to see us focus our time on, where I think that we really add value, and where I would really love the Secretary to see, this is where we take a leadership role.

DR. REYNOLDS: This is for September in general?

MR. BLAIR: This is for September, if it is possible. These are my suggestions for September.

Number one is the second round, a little deeper level that Stan could lead us on with respect to secondary uses, where we could get a little bit closer to things that could lead to actionable recommendations. That is one.

Number two is, if Judy could begin matching records to patients and get us started on that, I know that that is an area that everybody would love to find a solution on. If we could start to get in that area, where we could identify where help can be found, solutions could be found.

The third area is the CHI standards. I was disheartened when we heard testimony — and I think the testimony frankly is representative of the reality that the industry doesn’t — even though the Secretary, Tommy Thompson, announced the CHI standards publicly, since it wasn’t a quote mandate, a lot of the industry — even with HIPAA, when it was a mandate, a lot of the industry seemed to wait.

I would like us to revisit CHI to wind up seeing the status and what could be done to give it greater support. It is the foundation upon which we are building the future. I think we need to understand the status of that, so that if it needs reimbursement here or there, we could make recommendations to make sure it doesn’t languish.

DR. FRIEDMAN: I think there is a lot of confusion about CHI, both in the government and without. CHI was what the Secretary recommended for across-government use. At some point the government use then brings the industry along with it, it spills over beyond the government borders.

But I just want to clarify that that is where CHI is at the moment. It is still a government requirement.

MR. BLAIR: Maria, you are exactly right. I think that maybe we need to explore whether it is time to take another step, either within the government, or to encourage adoption outside of the government.

DR. STEINDEL: I’d like to comment a little bit on Jeff’s list and in general.

First of all, on the area of CHI, Maria’s comments are well taken. I can say, because I am in the middle of it and Mike is in the middle of it a lot and so are other people around this table, within the government CHI has a lot of traction.

The fact that it is not really having as much perceived traction outside of the government probably has to do more with the reorganizations that have occurred within the Office of the National Coordinator as its absorbed CHI project. That absorption became more operational. It always was in existence for over a year, but it became operational probably just three or four months ago.

So I think that it is premature to start asking specific questions about CHI. They haven’t even formed a new charter for CHI or how it is going to be operating. So it is difficult to look into that area. But I would like to change Jeff’s acronym from CHI to FHA. That is the area I think we should be looking at, because this encompasses more than just CHI. It is the area where the government is starting to expand the federal health architecture to cover all the federal health care. We should be more cognizant about what is going on there. It is an area of the Office of the National Coordinator, so it is an area that we should be expressing a lot of interest in.

I also was in very much support of Jeff’s comment that we should probably tread lightly in the area of the RFPs. There are two reasons for that. One is because functionally they are out of the Office of the National Coordinator, and we probably want to be briefed on them, but I don’t know much more than that what we can do.

Second of all, we have to realize that a lot of what goes on in the RFPs is also going to be contractually related. These people are being told to do this or that from their project directors and what was specified in the contracts themselves. So we may not have that much influence on the way the RFPs could go.

Of the list, the comment about Stan’s excellent presentations yesterday, I am in agreement with Simon; I think the next step on this is to present it to the full committee, to show them this wonderful area of exploration that can be used throughout areas of NCVHS. The tasks of what we can do with secondary uses of information should fall into the hands of the various subcommittees and work groups that are focusing on those areas, and work with them at the subcommittee and work group levels, help them instantiate those ideas into their work plans for the future.

So what that brings me down is, I think the main topic that I would like to see us focused on in September of this new list, and this does not exclude the existing things that we are going to be looking at, would be Judy’s topic. This is something that we have put off looking at for a long time. I think it is time to start in that area.

MR. BLAIR: Did I hear you say that you agreed with those three topics? You changed CHI to FHA, you agreed with Stan going through with the second, and having as the most important one Judy’s topic?

DR. STEINDEL: With slight modifications. The next step on Stan’s work is more or less, you said we need to extend Stan’s work; my feeling is, we actually need to reproduce Stan’s work maybe in a little bit different format in front of the full committee, and educating them.

MR. BLAIR: I thought we were talking about our next subcommittee meeting.

DR. STEINDEL: I’m saying I don’t think it should appear at our next subcommittee meeting.

DR. COHN: I think maybe what Steve is talking about is a November half day to focus on some of these issues.

Steve said enough stuff that it is hard to know even where to start. First of all, Steve, I think your comments about FHA are probably appropriate. I would also observe as a response to Jeff’s concerns about CHI that the CHI standards are the basis for the RFPs, as well as in legislation that is being — the draft as well as things that have been passed by the Senate and all of that, all of the stuff mentions the CHI standards as the basis.

Now, having said that, I think that we realize — I still feel there is a disconnect in the world of CHI, in the sense that as somebody who could implement something, it would take a lot of thought to figure out exactly how to implement CHI standards. You have got message format standards, you have got terminologies, you have got a choice of terminologies in many domains. There is no specifications of how all of this comes together.

Yesterday I think I heard that there has been a project going on that NLM has been funding for the last year to figure out implementation guides for all of this. I may be overstating, but that would be something to hear about a little more. Somehow that one went right by me. Am I missing that?

MS. AULD: It is moving in that direction. It is helping them to determine within HL-7 message standards when you use CHI.

DR. COHN: Without that, it is hard to put all these things together. So anybody that was looking at CHI standards, I think we all realize that there was that gap to make them usable.

MS. AULD: Let me point out first that Stan Huff is one of our technical leads on that part of the project. But the second thing is that Susie and I have been talking with Jeff and Harry about scheduling a full session, probably 90 minutes I think we were saying, to give an overview of the entire project, both sides of it.

DR. COHN: I think that would be a very useful thing for the subcommittee to hear.

I do think listening to FHA, when we heard from them at the full committee, it became very obvious that to dig down there would take a subcommittee action, whether it is September of November of whenever I think we would have to determine.

I think we have to decide exactly where this goes, but there are secondary uses of data, and then there is a piece off of it which isn’t exactly the same thing which is called reviewing the grand strategy for terminologies. I don’t mean to lay that down like the moose in the middle of the room here, but I think as we look at this one, how it relates. You talked about mappings yesterday. That should give us all pause; by the time we get done with our 40th different map between the two terminologies for different purposes, all of this may cause us to have to look back at, we recommended and created this edifice, are there other views about how to simplify some of this going forward. Whether that is a full committee issue or something for the subcommittee to go into, people like Don Dettmer have done some thinking about this. We may want to ask him to come in and give us some of his thoughts or whatever. But I think that some of this has major impact on all of the work going forward. I think that goes into, if it isn’t us, it is the full committee, but somewhere or other. I think it somehow needs to be handled, and we may want to take an early look at it.

Now, the final piece I’m just throwing out as a different cut on our conversations yesterday. There is one piece that I think Harry had brought up previously that I don’t want to have completely lost as we use our clinical brain, because we have only been primarily talking about clinical terminologies, clinical this, clinical that. There is the HIPAA RFI. I think we have a responsibility. I would remind you of the Secretary in the 500-day plan doesn’t only talk about clinical standards and AHEC and things like this. He talks about actual improvements in use of HIPAA standards, if you look at it, on eligibility and things like that. We may want to take a look at it sooner rather than later to see what progress there is, and if there is anything we need to do or support or recommend any actions to the Secretary.

MR. BLAIR: Could you clarify the HIPAA RFI? What is the HIPAA RFI?

DR. REYNOLDS: ROI.

DR. COHN: I’m sorry, it is still too early in the morning. ROI.

DR. REYNOLDS: If you remember, we did one hearing on that, and we had planned for this time to try to have some of the implementers come in and say what were some of the things that were impediments to them being able to implement.

DR. FRIEDMAN: I would just say, in terms of the HIPAA ROI, one of the challenges I found putting that hearing together was that people said there is no ROI at this point. There is no data. Part of that was because contingency plans were still in effect. We didn’t know what the full impact would be when those came off, although I think enough time has elapsed, we probably do. But the bigger takeaway was that the true ROI is on those different transaction steps that people were just starting to get to. That is where the real return is going to be. So I would just like to throw that out there for consideration.

DR. STEINDEL: Just a quick comment on what Simon was saying concerning timing of when things should come before us. FHA after about a year of real existence has taken a look at its operational structure, and has decided to reorganize it, and is in the process of reformulating just where BINs fall. We were having a discussion about BINs, and that process is underway right now.

There is also an initial FHA report that is due around September 30. So if we are looking at timing, we probably would not want to do this in September, because things are in a state of flux.

DR. FRIEDMAN: But we do want to hear how that all shakes out.

MS. AULD: One comment about the mapping. Much of the work that we are doing right now is essentially developmental. We are figuring out on the technical side exactly how we are going to represent it and who needs to do it. We are working out a lot of the basic issues.

Our starting list is based on recommendations that came from this committee and federal agencies who came forward and said, if we are going to use this chi standard, we need this map first. So those are our first hits. But it is very quickly going to reach a point where we are going to need input and recommendations on how to go forward and how to decide exactly how many usage cases are reasonable for two vocabularies, and how to usefully move forward on that. We would welcome recommendations on that.

DR. HUFF: Just reflecting on what folks have said, with the secondary use of data, I agree that it may be that that categorization isn’t appropriate. What we need to talk about are more specific subjects, and focus on the billing aspects, the automated billing sort of thing, and another one that would focus on quality. I guess there are some infrastructure things that enable all of those, but in another sense you only make progress if you have got a group of people who are working on a more specific project.

But it seems like we maybe need some committee time or maybe need to think about recommendations that we can make, some way that we formulate that in a way that we present it to the full committee. I don’t think we would want to have more hearings necessarily in September, but we may want to take some time to plan either recommendations or how we would present a work plan for that to the full committee.

I really am interested in the patient and data connection, and I give a second to that. I would give a very hearty second to what is the grand scheme for the terminologies. I put that down, and I would just expand on that a little bit.

As part of this contract with HL-7 and NLM, there is a lot of things going on. At NCI there is the data element repository and a lot of CA Big and DSR, and I can’t even remember all of the parts of stuff that are over there. At the DoD, I know they put out an RFP for a terminology services bureau. I’m not sure how that relates back. I know that there are a lot of contractors and other people that are working with CDC for a real deployment of systems, and they are doing something, but I don’t think we are providing real code set repositories for what they need.

I haven’t heard from the FDA for awhile about what has happened with all of the drug identifiers, and are they really passing those off to the NLM, and are those getting distributed yet, and how has that part progressed. Then we heard some about what has happened at the NLM.

But it seems to me that there are large investments going on in the federal government. I haven’t mentioned the VA. The VA are working on a large scale project to try and unify terminology for all of the VAs. They are making a new structure for their terminology and repository.

So I think there is a bunch going on there. We could ask people to report what their activities are. In some sense it is chi related or FHA related, but it is a small aspect of that. In another way, I think it is really important.

I think unfortunately, the good news is, people are doing good work. The bad news is that it is really not as coordinated as you had hoped. It is people taking care of their own needs, and we are not ending up with a place that all of these code sets are, that people have easy access, they can download them, they can subscribe and get updates, the kind of thing that you would hope for in the future.

So I add a strong second to that idea; what is the global picture for vocabulary.

MR. BLAIR: I am wondering if I am hearing some connections here. I was nodding my head so vigorously when Stan was making his comments that it almost fell off. I almost think that I heard from Vivian that she is inviting me to begin to explore how we take all of the mappings and how we take all of the work NLM is doing. They have already got some plans in the future, as she mentioned, heading in the direction of implementation guides and how you package these so that it becomes easier to use in the private sector and the public sector.

It sounded to me as if they were both talking about some of the same things that Stan was saying, broader than just NLM. It is all these other pieces and how do they fit together. Just like we had at one point recommended the need for a National Health Information Infrastructure to pull things together, I am almost beginning to feel like this could be the beginning of, does there need to be a new entity within NLM, or that NLM could hand things off to or something to help and enable and bridge things.

Are my comments resonating both, Vivian, with you and Stan, with you? Are we all converging on the same type of thing?

DR. HUFF: I still think that the HLM is the right place to coordinate this activity, as we have said in our previous recommendation. At the same time, I think we are not there yet. So whether it needs a new part or a new emphasis, I’m not sure.

MR. BLAIR: Additional resources?

DR. HUFF: Additional resources. We just heard things where people said, yes, we want to use SNOMED, and when we download it, it takes us hours to do it. There might be some operational things there.

Anyway, I think there are issues that I would like to know more about, and then formulate recommendations that would help that converge more, and cause resources to be available so that they could do the things that need to be done.

MR. BLAIR: I was asking for Vivian to see if we were on the same track on this.

MS. AULD: Yes, I think we are on the same track. My only slight clarification is that NLM is not creating the implementation guides, we are facilitating assisting those who more rightly should be doing HL-7 in this case. But yes, overall I think you are definitely on the right track.

DR. COHN: I think I was seconding some of Stan’s comments. The NCVHS has previously recommended — Jeff, including some of the documents that you had authored — that the NLM be the repository of all of this. I don’t think that is up for questioning.

To my view, I am almost thinking we need to start with Creshute and move forward, how things are put together, by rethinking some of the basic tenets and assumptions, are there ways to simplify some of what is going forward.

I was struck yesterday that there is a tremendous amount of complexity that we have in this system, the way that we are doing it right now. It is showing up in all sorts of ways, be it the multiple different use cases and the mapping conundrums. It is showing up in the fact that the NCPDP people — seemingly it is all in front of them, but it is so big that they couldn’t find anything.

I just think we would have to think really hard about exactly where we hit all of this from, but just a look back to see — you have to realize that the government is following our strategy on this one. I think there is nothing wrong with our strategy, but it probably is appropriate that we update it or at least we evaluate it or whatever to make sure that it is the optimal way to go forward and meet our time lines and deadlines.

I just speak for myself, but as I think about all of this stuff at the end of the day, I have this vision and have had for years that we will have clinical terminologies well connected to administrative terminologies, that if somebody out there in the world, be it my organization, Kaiser, be it the Blues, be it Humana or whatever, that are using clinical terminologies in their systems, that there will be ways that are approved by top to bottom everywhere that we can map them to the appropriate administrative terminologies and have everything work as needed.

I think that is part of the vision of secondary uses of data. Certainly we heard a lot of complexity yesterday around all of this, and it may just cause us to think about, are there some better ways to get to that end point. Anyway, I’ll stop here.

DR. STEINDEL: I would like to comment on one aspect of what Stan was raising. This also picks up a little bit on Simon’s comment.

This is the area of terminology distribution for use, the differences between what the UMLS is doing, which is terminology distribution so you can get the terminologies, but there is also terminology distribution for use.

Stan mentioned the VA project and its terminology servers to service the whole VA. That is a very closed system, internal within the United States. It is well covered under the SNOMED license, and we have no problem using it, and it is being deployed.

Stan also mentioned that the DoD is looking at developing another similar system. Their is also pretty much well controlled, and within the scope of the license as I understand it at this point in time. It is not quite as clean as the VA, because the DoD does act internationally with other health care organizations to service troops. But we did cover that under the license. So DoD I think is proceeding forward fairly well.

But then we take two other organizations, both of which were mentioned, and that is NCI and CDC, who are both also looking at terminology deployment for use. Both of us have run into licensure barriers because it turns out that our work is being used by international partners that we thought were covered under the license. Indeed, the language that is in the license was put in deliberately to cover CDC.

The first instance we had of potential deployment of SNOMED internationally was a use case that we couldn’t cover under the license. So we are having problems with doing universal deployment of terminologies in a controlled fashion, because of our international partners. The Library is aware of this problem, SNOMED is aware of this problem, and we are investigating what possibly can be done about it in the next phase of the licensure.

But I think this is one barrier that is holding up some of what Stan is looking at, and this universal global technology that Simon was talking about. When he was talking about this world terminology, and the next words he was using were all national, U.S. focused, which goes together. But I was just saying that there is an international component that is turning out to be much stronger than we had thought two or three years ago.

In part we had that mentioned to us at our last full committee meeting, and the scenario that we do need to start to explore more, I don’t know at what level or where.

MS. BURKE-BEBEE: Harry, if I could move to the practical side of our work plan, I had made a request to you and Jeff about the presentation, and it would be in February, about the NLM project. I am helping Vivian with the EHR side of that.

We are finding some very interesting things, specifically patient matching. So what I would suggest to you is that I could help as a staff person to help Judy and help Maria. In February if it works for your work plan, we could make a presentation on NLM. There could also be a panel that I could assist in forming to talk about the patient matching area.

The other thing, just one last thing to say, there is going to be an implementation guide that comes out of the NLM project. It is going to be on the EHR side. It is dealing with the meta transaction, to more components of the EHR from point A to point B. So we will have a hard product, an implementation guide.

MR. BLAIR: Susie, thank you for the offer on the matching records to patients work. Are you indicating that we shouldn’t have testimony this September on that topic, and that we should wait until February when you can pull it together with the other things?

MS. BURKE-BEBEE: I am offering February. I can certainly assist in February. I think it is an issue that could be more than one panel, more than one day.

MR. BLAIR: So in other words, you feel it is okay if we go forward in September, but you would be able to add more to it in February?

MS. BURKE-BEBEE: I think so.

DR. REYNOLDS: But September could be an overview, February more of actual detail.

MS. BURKE-BEBEE: Detail. It is an area of maturity that we are finding in the study that we are doing, so it is a very interesting area.

DR. WARREN: As I listen to everybody talking, one of the things that hits me is the whole CHI implementation of what that means. I am no longer sure that I have a good idea about what CHI is.

Part of that is that when the work was being done, I got the impression that it was mandatory of government agencies to implement CHI. But since then I have heard that that is not the case, that it may be a voluntary use. I don’t know whether that is in response to some of the difficulty of implementing it.

When we start hearing about the VA and DoD doing different things with terminology, that was not the impression that I had from the CHI recommendation. I thought we had already selected terminologies and what their uses would be.

So I guess I am wondering if maybe we need to have some report — and I wish Steve hadn’t walked out — a report maybe just on CHI and where it is today, especially since it has been reorganized under ONCHIT, and how it relates to FHA.

MR. BLAIR: Vivian may be able to answer the question, though.

MS. AULD: Possibly, although I too wish Steve had not left the room when he did.

MR. BLAIR: Specifically, is CHI standards mandatory for federal use?

MS. AULD: It is my understanding that it is still mandatory for federal use. Steve is back now, so he can tell me if I’m right. Judy is asking whether CHI was originally mandated for use in federal systems. It is my understanding that it is still the case for systems that we are developing for the future, it is mandatory that you use CHI standards. We are not doing it for legacy systems, so maybe you are hearing from people that are working on legacy systems, and that is not using the standard.

DR. WARREN: So if they are doing maintenance work on legacy systems —

MS. AULD: They do not have to use them.

DR. WARREN: They don’t have to implement CHI. They can continue on with what they are doing. It is everything new.

MS. AULD: Exactly.

DR. WARREN: Then Steve, my other question is, I’m not sure I understand the relationship between CHI and FHA. When you were talking about it, I did, and then as I was listening to the conversation, I lost that understanding again. Would it be worth our while to actually hear a presentation on how the two fit together?

DR. STEINDEL: I think that is why I said it would be best to put this off until November, because right now what they are doing is reorganizing to fit together better.

MS. AULD: They are also waiting to see who is going to get awarded the different RFPs and what is going to be the role of AHEC. All of these things are effectively swirling around each other, and we are waiting to see how they settle.

DR. WARREN: There is some implementation that all these come together in a grand alignment.

MS. AULD: Exactly, but it is not decided how, yes.

DR. FITZMAURICE: There is another point that Lee Jones made when he testified to the full committee on FHA. He showed how CHI fits in with FHA on a map, but he also alluded to it in response to a question. He says ONCHIT doesn’t have a lot of resources until Congress or the Department gives them resources. They need things like — he probably didn’t say this — authority for hiring real fulltime government workers. I think that once they get authority and some real FTEs and things like that, then we will start seeing more representation and more representatives on the particular areas.

I think the RFPs are a bold step forward. I think that there are many laws in Congress right now, seven of them, and many of them — endow is not the right word, but they authorize an office in the Office of the Secretary and give it things to do.

When ONCHIT received FHS and CHI, they got the mission and the function without the resources. So what we are seeing is them doing as much as they can with few resources in ONCHIT. Fortunately they are bolstered by a lot of good people in other agencies, including HHS, and they are bolstered by some good people with contract support. So we see that moving forward, but things are in a little bit of flux right now.

MR. BLAIR: You said, I think there are seven of them. What were you referring to?

DR. FITZMAURICE: Seven bills in Congress that deal with health information.

MS. BURKE-BEBEE: I have been talking to ONCHIT, too. They have expressed an interest about coming in February. They are interested in the NLM project, of course. So I am suggesting now that it could be a good time for us to hear more about the RFPs, since they will be going forward in September or October. That time lag until February would allow for enough time to have passed to maybe hear something substantial. They have expressed an interest to participate in February.

DR. REYNOLDS: Time check, 30 minutes. We have talked about a lot of subjects. So we have got September, November and February, so let’s try to solidify September, and then get some kind of a straw situation in place for the other two so that we can make sure that we can go out of here with a good plan.

MR. BLAIR: It sounds like we still only have one item for September.

DR. REYNOLDS: Matching records to patients, an overview. Stan did ask if we could have some committee time to at least discuss even prior to the November full committee, to discuss what would be the next step on secondary data. So we could have that for a period of time.

I would like to consider that we went halfway or three-fourths of the way through HIPAA ROI. We started to draft something that could be some kind of a finding out of it, but it never went anywhere because we didn’t finish it.

The thing is, the committee is on record that we had a hearing. The committee is on record that we did something. The committee is on record that we got testimony, but I’m not sure we have closed the subject. I am not pushing HIPAA or anything; I’m just trying to think back to unfinished business. We are kind of in the middle.

DR. COHN: Well, Harry, let me push HIPAA, because I think HIPAA is important. We had a hearing. What we discovered was that the 837 — there were problems with compliance guides which were bothering everybody, but the ROI related to all of the other implementations. The next hearing was supposed to be about all of that. So we are certainly not three-quarters of the way through. We are about 40 percent of the way through on that. So we needed to hear from CAQH to find out what they are doing. We need to hear about other opportunities relating to implementation of these other standards. Maybe we needed an update about what is happening with the compliance guides. But I don’t want us to ground in that one because it is a bother.

MR. BLAIR: I think one of the areas also that we were hoping to find additional information on to resolve this was to hear from the practice management system vendors and the claims clearinghouses, with respect to why a lot of the practice management system vendors have deferred to the claims clearinghouses on this. So that may have been additional testimony that would help us.

DR. REYNOLDS: I think another reason that would be very helpful right now is, as the whole EHR, EMR, everything comes out, a lot of these same practice management vendors — anything we could do to identify impediments that have hurt them in HIPAA could be a plus as all of them move forward.

When you think of this mapping and you think of the terminology, you think of everything that everybody has been talking about the last two days, it is the same people in the same doctors’ offices, whether you give them a Vista or whatever you give them, they still have got a practice management system that somewhere is in play. If we can get a sense of what are the impediments as they face these smaller players as they try to do this, it might not hurt in recommending as these other things start coming out, what those impediments might have been and how they could be addressed in the future from their viewpoint. I think that might be a service that we can do, not just for what happened now, but how can it go forward, make a difference.

So right now we have the matching records to patients. That is probably about a half day, or a little more if we wanted.

DR. WARREN: I think that just depends on what we can come up with, because we are going to need to start filling that in pretty quickly, but about a half day.

DR. REYNOLDS: Then Stan, if we took an hour, hour and a half, for a briefing on the secondary uses, what do we do next and what does that mean.

DR. HUFF: As I thought more about it, and this might go counter to some things that we said earlier, but Kent Spackman was almost lined up to speak to us this time. Kent is deeply involved with SNOMED. Also, one of the other people that has been interested is Chris Schute. I wonder if we did a half day, had those two guys talk, get our minds back into that subject, and then take the second half, have them do between the two of them an hour and a half or something, then we took the rest of that half a day and formulated what we want to do in terms of recommendations and moving this back to the full committee.

DR. REYNOLDS: Do we want to then do a half a day on the whole HIPAA ROI, where we would have somebody come in and talk about the 27X transactions, how implementations are going, and get an update from the Department and CMS and so on on that, and then have a couple of practice management vendors come in and tell us what is going on. That would be a day and a half.

DR. COHN: And also, just to remind the subcommittee — I always like to remind them of their responsibilities — as you know, the full committee normally responds to NPRMs. I was just whispering with Maria, God knows what is going to be out at that point, but there may be some NPRMs that we need to at least discuss, whatever the NCVHS response would be, knowing that these are within our area.

DR. FRIEDMAN: The Stark and Safe Harbor, I can’t talk about them because they are not out, but they may have some additional areas of interest for the subcommittee.

DR. REYNOLDS: Let me ask one other thing before we solidify September. Are there any letters that we plan to put out as a committee this year that we need to make sure we do something with? There may be letters coming out of some of our things we do, but I just want to make sure, if there are, then we better be involved in it pretty quick.

DR. COHN: We commented on the NPRMs, which is a letter.

DR. REYNOLDS: Yes, but those aren’t out yet, so we can’t do that. I’m saying, is there anything that is on our plate. I would think that we would want to make some kind of comment on the HIPAA ROI, possibly.

DR. COHN: Yes.

DR. REYNOLDS: Also, we talk about subjects, and I want to step back and make sure, if we have letters, none of that has come up, I want to make sure we get ourselves aligned, so that if we have got something that we are going to do, then we have got to make sure we either get drafts going, or we decide what meeting we will start thinking about it.

DR. COHN: I thought that there might actually be a letter out of our testimony yesterday, which I once again throw out. I heard for example that issue of pilots starting in January, what is the Secretary going to do with these other functionalities as they move forward, advising the Secretary about the need for ongoing pilots and all of this of new functionalities as they come on. I know it was something that I heard.

MR. BLAIR: Can I comment on that? Part of my suggestion is limits, and not wanting to say more than we need to. But Harry and I had an idea when we were reading some of the information before the meeting on what a beautiful job the industry did in documenting the status of each of the recommendations that we had set forth last September.

That document I thought is a wonderful example of the effectiveness not only of the industry, but also of NCVHS in terms of the leadership and guidance. The suggestion I am about to make isn’t the way we normally do things, but this is an idea.

I think it would be very nice if we essentially wrote a letter back to all of the SDOs on behalf of the industry, so it is NCPDP, X-12, HL-7, STM, thanking them for the response that they had to our recommendations from last September, attaching that document to it, so it is very brief. It would be one or two paragraphs, no more, and copying the Secretary as a courtesy. It is something that we could get out in a short period of time.

DR. FRIEDMAN: This would be a thank you or an acknowledgement?

MR. BLAIR: An acknowledgement, recognition of the outstanding industry cooperation and effort, sense of urgency and accomplishment

DR. REYNOLDS: Simon, process check. Does any letter that goes out from this committee have to go through the full committee?

DR. COHN: I think it would be something, if we had it for the executive subcommittee, we could take a look at it. Unfortunately Marjorie isn’t here to comment. I guess it would be a question of — it is hard to imagine that every thank you letter that we write has to be voted on by the full committee. The full committee is meeting in September, so it would not be far from now, but we can decide at the executive subcommittee if this was just purely a formality.

DR. REYNOLDS: We will try to have the draft ready for that. I think we have sent letters like that in the past.

DR. FITZMAURICE: It would depend upon how public you want to make it. If we want to tell the world what a great job industry has done, then it would carry more weight with the signature of the chairman of NCVHS. If you want to thank somebody for showing up for testimony and hearing, that would be something different.

DR. COHN: It sounded like a chair of the full committee letter, I think. However, there isn’t necessarily a requirement that anything the full chair signs has to be voted on by everybody.

DR. REYNOLDS: No, we would have a draft for the executive subcommittee. Then we will look at whether or not that supersedes a need to write anything directly to the Secretary. Then after the September hearings, we could then finalize something that we might want to send forward on HIPAA. We have got a piece of it now, then if we had September hearings, we could start putting something together.

DR. COHN: For the November full committee meeting. Great.

DR. REYNOLDS: So that sets September. Let’s think about November just briefly.

DR. FRIEDMAN: Were you going to have any sessions on — briefings on some of these regs and other pieces that are coming out?

DR. REYNOLDS: We have got a day and a half here.

DR. FRIEDMAN: You have got a day and a half already, okay, because some of this stuff is time limited.

DR. REYNOLDS: That’s fine. We are setting up a structure, so if we should move something off, fine.

DR. FRIEDMAN: You can have the briefings whenever you want them. Some of these will be coming out sooner rather than later.

DR. REYNOLDS: Help us with the timing then. Which ones would you recommend?

DR. FRIEDMAN: This is all going to be close. I don’t know on timing.

DR. STEINDEL: My comment on that, Maria, we do know that we have to hear about them. The problem is that we don’t know when we can hear about them. We know it will probably be either in September or November, depending on when they come out. I think that is the only way we can plan for it. If we block off time now for September, how many times has this subcommittee blocked off time like that, and all of a sudden it hasn’t come out?

DR. FRIEDMAN: And we have the reverse problem, because we have a full hearing, given the topics that we have. We have meaty days in September. If this stuff breaks, you are going to want to hear about it, I suspect, in September. So I am just putting that out for peoples’ consideration. I wish I had a better sense of timing so we could plan for it.

MR. BLAIR: I don’t understand why the federal government doesn’t accommodate itself for NCVHS.

DR. COHN: I would say on this one, without micro managing the process, not that we have ever done that before, I think I would defer to the co-chairs on modifications to the agenda based on late-breaking events.

DR. REYNOLDS: Okay, we will take that assignment. In November, a couple of things we had listed. We will work on November for the big subjects and February for the big subjects. That way everybody can get a sense of it. I heard FHA for November, and I heard a grand strategy for terminology, those two bigger subjects for that. Then in February, I heard the update from NLM and the possibility of the ONCHIT RFP, were two items.

DR. STEINDEL: I just got a brain wave of some type. This has to do with the September schedule, leaving some block of time available for flexibility, et cetera, and Stan’s comments about having Kent Spackman and Chris Schute address us.

That might be good to put in both with secondary use of data and grand strategy for terminology, and maybe put together a panel with Don Dettmer, Kent Spackman and Chris Schute for November.

DR. COHN: For us or for the full committee?

DR. STEINDEL: For us. Then that takes a little bit of the block that we gave to Stan and makes it a little bit more flexible in September, in case we have to meet Maria’s needs, and also allows us flexibility for November, because we haven’t blocked off as much.

DR. COHN: So clarify for me what you are thinking about for the November subcommittee meeting versus the November full committee meeting. I am embarrassed; I don’t have a November —

DR. STEINDEL: We don’t have a committee meeting in November.

DR. COHN: Okay, September.

DR. STEINDEL: The late winter meeting.

DR. COHN: So explain to me again how we are planning for November, if we do something at the full committee meeting, how that would differ.

DR. STEINDEL: If we do something at the full committee meeting, we would probably discuss exactly what we are going to do in September at our subcommittee meeting, but basically it would be an educational session on secondary uses of data, and thoughts in that area. We would expand what we heard about secondary uses of data in our November meeting.

DR. COHN: In our December meeting?

DR. STEINDEL: December meeting.

DR. COHN: Okay. Thank you.

DR. REYNOLDS: So does that say we are moving Stan’s half day to December?

DR. STEINDEL: We are moving one quarter of Stan’s half day.

DR. REYNOLDS: So Stan is still going to tell us what we should do next. But we are going to have further testimony in December. No testimony in December, only the discussion amongst the committee.

DR. COHN: Let’s defer to Stan to see how he wants to sue his time.

DR. HUFF: The tricky part is, Kent was available in September, but I think he was not available in December.

DR. REYNOLDS: How about one of them and not both?

DR. HUFF: That would be okay, too.

DR. REYNOLDS: Why don’t we do that?

DR. COHN: I don’t think we need to do this yet.

MR. BLAIR: Maybe the other thing is that matching the records to the patients, that might not be quite a half day, so there might be an hour there and an hour out of Stan, so maybe those two hours, one of each. The same thing with the testimony with the practice management system vendors. So there may be a little latitude there.

DR. COHN: I think I was going to re-emphasize what I was saying about micro management. I do realize that we want to get everything down here, but we are in late July, this next meeting of the subcommittee will be late September. I think we can have a variety of options to bring forward, but the world continues to change, so we should probably try not to be too definitive down to the micro. We might want to do a conference call.

DR. REYNOLDS: Here is what we will do. We have got four possible subjects in September: secondary uses, matching records, HIPAA ROI and NPRMs, and we need to work that schedule. We take that as an assignment. In December we have the FHA and the grand strategy in terminology, which we will work those. In February we have the NLM and the ONCHIT RFPs. We will leave it at that level for right now. Obviously we will revisit February in December again when we meet. But we will go with that as a structure. Everybody in concurrence?

MR. BLAIR: Yes.

DR. REYNOLDS: Is there any other business that anybody wants to cover today?

DR. COHN: And the dates for these upcoming hearings are?

(Discussion off the record regarding future meeting dates.)

DR. STEINDEL: Do we need to block off any time in the near future for the e-prescribing pilots?

DR. FRIEDMAN: I would put it on the list, because the RFP is hopefully going to be on the street pretty quickly.

DR. STEINDEL: So we are going to react to that just based on the fact that it will come out as an RFP, and we do need to hear about it, but our timing is governed by the RFP.

DR. FRIEDMAN: I suspect you are probably going to want to hear about the awards that we make, too.

DR. FITZMAURICE: It depends on what you want to hear. You can read the RFP, but once it is out, nobody can talk about it in evaluation. We can’t talk about it beforehand. We can tell you what is public.

MR. BLAIR: Maria, since you have a sense of what they are going to be, is there really going to be very much of value that we can offer once they are out? Other than having it presented to us so that we are informed.

DR. FRIEDMAN: No.

DR. STEINDEL: Thank you, Jeff. I think that was the basis of my question, how much time do we need to allocate for it. My sense was that it was just an informational item.

DR. REYNOLDS: We have our large subjects. We need to fit these things in. I think we all agree to that. Is there any other business we want to cover?

DR. COHN: Maybe the following comments. A, it sounds like there is probably going to need to be a conference call with the subcommittee at some point to firm things up, after the executive subcommittee meeting, probably late August. Maybe we can handle it during the full committee meeting. I will defer to you guys on that one.

I think I would also observe that it would probably be timely for the subcommittee chairs to begin to identify dates in 2006 for hearings and meetings. I know peoples’ schedules in 2006 are beginning to get filled up. So I would ask the leadership from the co-chairs to begin to think about that, and then the whole committee will be checked further on that.

I want to thank the co-chairs for leadership. I think it has been a very interesting day and a half.

DR. REYNOLDS: I think this was a very good day and a half. Thank you. The meeting is adjourned.

(Whereupon, the meeting was adjourned at 10:25 a.m.)